Endocrinological and Neuronal Aspects of Bariatric Surgery

Recruiting

• Conditions: Bariatric Surgery; Obesity
• Interventions: Dietary Supplement: conservative diet; Procedure: bariatric surgery

• Registration Number: NCT04634929
• Lead Sponsor: University of Heidelberg Medical Center

Brief Summary

The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Study Start: 2020-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• planning to undergo bariatric surgery
• planning to take part in a conservative diet

Exclusion Criteria

• inability to undergo fMRI
• psychiatric disorders
• metabolic disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conservative diet participants	conservative diet	participants with obesity planning to controlled conservative behavioral weight loss program
bariatric surgery participants	bariatric surgery	participants with obesity planning to undergo bariatric surgery

Primary Outcome Measures

Name	Time	Method
Change in Functional magnetic resonance imaging following intravenous glucose infusion.	2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.	Change in responsivity of the hypothalamus (extracted as percent signal change) as the core region of homeostatic control will be assessed after an intravenous glucose infusion (by calculating the area under the curve of hypothalamic responsivity) before and after bariatric surgery or dietary intervention.
Assessment of glucose-induced changes in peripheral ghrelin using blood samples.	15 minutes before and 15 minutes after functional magnetic resonance imaging	Blood is collected to measure the concentration of peripheral ghrelin as an indicator of hormonal satiety signaling. Blood samples are collected at the beginning and end of each experimental session to assess the influence of intravenuous infusion of glucose on ghrelin signaling. Blood samples will be analysed using using commercially available kits (enzyme-linked immunosorbent assay).
Experimental functional magnetic resonance imaging task (gustatory stimulation).	2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.	Neuronal gustatory processing of food stimuli will be assessed (ingestion of sweet liquids using a gustometer) using a general linear model (comparing brain activation during ingestion of sweet liquids with brain activation during the ingestion of water) and within as well as between groups analyses. Changes in neural gustatory processing of food stimuli will be assessed before and after bariatric surgery or dietary intervention.

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany